ROSUVASTATIN PENSA

Package leaflet: Information for the patient

Rosuvastatin Pensa 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What Rosuvastatin Pensa is and what it is used for
  2. What you need to know before taking Rosuvastatin Pensa
  3. How to take Rosuvastatin Pensa
  4. Possible side effects
  5. How to store Rosuvastatin Pensa
  6. Contents of the pack and other information

1. What Rosuvastatina Pensa is and what it is used for

Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Pensa because:

• your cholesterol level is high. This means you are at risk of heart attack and stroke. Rosuvastatin is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.

You have been prescribed a statin because changes in diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking Rosuvastatin, you must continue your cholesterol-lowering diet and maintain physical exercise.
Or

• you have other factors that increase your risk of developing heart attack, stroke, or related health problems.

Heart attack, stroke, and related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why it is important to keep taking Rosuvastatina Pensa
Rosuvastatina Pensa is used to correct levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin can reduce "bad" cholesterol and increase "good" cholesterol.
• It works by helping to block the body's production of "bad" cholesterol and also improves the body’s ability to remove "bad" cholesterol from the blood. For many people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to their narrowing.

Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain, resulting in a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You must continue taking Rosuvastatina Pensa, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to the formation of fatty deposits. However, you must stop taking Rosuvastatina Pensa on medical advice or if you become pregnant.

2. What you need to know before taking Rosuvastatina Pensa

Do not take Rosuvastatina Pensa:

• if you have previously had an allergic reaction to Rosuvastatina Pensa or to any of the ingredients of this medicine;
• if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Pensa, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina, using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle pains or aches;
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you have ever developed a severe skin rash, peeling of the skin, blisters, and/or mouth ulcers after taking Rosuvastatina Pensa or other related medicines. If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

In addition, do not take Rosuvastatina Pensa 40 mg (the highest dose):

• if you have moderate kidney problems (if in doubt, consult your doctor);
• if your thyroid is not functioning properly;
• if you have repeated or unexplained muscle pains or aches, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian);
• if you are taking other cholesterol-lowering medicines called fibrates. If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Pensa.

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle pains or aches, a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pains or aches, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• if you regularly consume large amounts of alcohol;
• if your thyroid does not function properly;
• if you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir; please read the section "Other medicines and Rosuvastatina Pensa";
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and rosuvastatin may lead to serious muscle problems (rhabdomyolysis);
• if you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you);
• if you have severe respiratory insufficiency;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor needs to choose the appropriate starting dose for you.

If you fall into any of the above categories (or are unsure):

• do not take Rosuvastatina Pensa 40 mg (the highest dose) and consult your doctor or pharmacist before starting treatment with Rosuvastatina Pensa at any dosage.

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test measuring liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with Rosuvastatina Pensa.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatina Pensa. Discontinue use of Rosuvastatina Pensa and seek immediate medical attention if you experience any of the symptoms described in section 4.

Children and adolescents

• if the patient is under 6 years of age: Rosuvastatina Pensa must not be administered to children under 6 years of age.
• if the patient is under 18 years of age: Rosuvastatina Pensa 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplantation), warfarin, ticagrelor or clopidogrel (or any other medicine used to thin the blood), fibrates (such as gemfibrozil, fenofibrate), or any other medicine used to lower cholesterol (such as ezetimibe), antacids (used to neutralize stomach acid), erythromycin (an antibiotic), oral contraceptives (the pill), regorafenib (used to treat cancer), hormone replacement therapy, or any of the following medicines used to treat viral infections including HIV or hepatitis C, either alone or in combination (see section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. The effects of these medicines may be altered by Rosuvastatina Pensa, or the effect of Rosuvastatina Pensa may be altered by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Rosuvastatina. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, soreness, and serious muscle problems (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take Rosuvastatina Pensa if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Pensa, you must stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Rosuvastatina Pensa by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive vehicles and operate machinery while taking Rosuvastatina Pensa – it does not affect their ability.
However, some people may experience dizziness during treatment with Rosuvastatina Pensa. If you experience dizziness, consult your doctor before driving or operating machinery.

Rosuvastatina Pensa contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking Rosuvastatina Pensa.

Rosuvastatina Pensa contains azo colouring agents.
These may cause allergic reactions.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

For a complete list of all other ingredients, see section "Contents of the pack and other information".

3. How to take Rosuvastatina Pensa

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatina Pensa for high cholesterol:
Starting dose
Treatment with Rosuvastatina Pensa should begin with a dose of 5 mg or 10 mg, even if
you previously took higher doses of other statins. The choice of starting dose depends on:

• your cholesterol level;
• your risk of having a heart attack or stroke;
• any factors that may make you more sensitive to possible side effects.

Check with your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatina Pensa for you.
Your doctor may decide to prescribe the lowest dose (5 mg) if you:

• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• are over 70 years old;
• have moderate kidney problems;
• are at risk of muscle pain or cramps (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to determine the most suitable dose for you. If treatment starts with 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and finally to 40 mg. If treatment starts with 10 mg, your doctor may, if necessary, decide to double this dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatina Pensa is 40 mg. This dose is administered only to patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels have not been sufficiently reduced with the 20 mg dose.
If you are taking Rosuvastatina Pensa to reduce the risk of developing heart attack,
stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.
Use in children aged between 6 and 17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the most appropriate dose of Rosuvastatina Pensa for you. The maximum daily dose of Rosuvastatina Pensa is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily. Rosuvastatina Pensa 40 mg tablets must not be used in children.
Administration of the tablets
Swallow each tablet whole with a glass of water.
Rosuvastatina Pensa should be taken once daily. It can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Periodic cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains at the appropriate levels. Your doctor may decide to increase your dose until the amount of Rosuvastatina most suitable for you is reached.
If you take more Rosuvastatina Pensa than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the hospital doctor that you are taking Rosuvastatina Pensa.
If you forget to take Rosuvastatina Pensa
Do not be alarmed; take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Rosuvastatina Pensa
Inform your doctor if you intend to stop taking Rosuvastatina Pensa. If you stop taking Rosuvastatina Pensa, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to be aware of which of these side effects may occur.
They are usually mild and disappear quickly.
Stop taking Rosuvastatina Pensa and seek immediate medical help if you experience any of the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing;
• severe itching of the skin (with raised hives);
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatina Pensa and contact your doctor immediately if you have:

• unusual muscle aches or pains lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects and, rarely, these have progressed to a condition causing muscle damage, potentially fatal, known as rhabdomyolysis;
• lupus-like syndrome symptoms (including rash, joint disorders and effects on blood cells);
• muscle breakdown.

Possible common side effects (may occur in 1 to 10 and 1 to 100 patients)

• headache
• stomach pain
• constipation
• feeling unwell
• muscle pain
• feeling weak
• dizziness
• increased amount of protein in the urine – values usually return to normal on their own without needing to stop taking Rosuvastatina Pensa (only for Rosuvastatina Pensa 40 mg)
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Possible uncommon side effects (may occur in 1 to 100 and 1 to 1,000 patients)

• skin rash, itching and other skin reactions
• increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with Rosuvastatina Pensa (only for Rosuvastatina Pensa 5 mg, 10 mg and 20 mg).

Possible rare side effects (may occur in 1 to 1,000 and 1 to 10,000 patients)

• severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina Pensa and seek immediate medical help
• muscle damage in adults – as a precaution, stop taking Rosuvastatina Pensa and contact your doctor immediately if you have unusual muscle aches or pains that last longer than expected
• severe stomach pain (inflamed pancreas)
• increased liver enzymes in the blood.

Possible very rare side effects (may occur in fewer than 1 in 10,000 patients)

• jaundice (yellowing of the skin and eyes)
• hepatitis (liver inflammation)
• traces of blood in the urine
• nerve damage in arms and legs (numbness)
• joint pain
• memory loss
• breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• diarrhoea (passing liquid stools)
• cough
• shortness of breath
• oedema (swelling)
• sleep disorders, including insomnia and nightmares
• sexual problems
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• tendon injury
• persistent muscle weakness.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatina Pensa

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister pack/labelling, after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina Pensa contains

• The active substance is rosuvastatin. Rosuvastatina Pensa film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are: calcium citrate, microcrystalline cellulose, hydroxypropylcellulose, mannitol, anhydrous lactose, crospovidone and magnesium stearate.
• Rosuvastatina Pensa 5 mg film-coated tablets also contain polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, tartrazine (E102), sunset yellow FCF (E110) and indigo carmine (E132).
• Rosuvastatina Pensa 10 mg, 20 mg and 40 mg film-coated tablets also contain polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, tartrazine (E102), allura red AC (E129), sunset yellow FCF (E110) and indigo carmine (E132).

Description of the appearance of Rosuvastatina Pensa and package contents
Rosuvastatina Pensa is supplied as tablets in four dosage strengths:
Rosuvastatina Pensa 5 mg film-coated tablets are yellow, round and biconvex.
Rosuvastatina Pensa 10 mg film-coated tablets are pink, round and biconvex.
Rosuvastatina Pensa 20 mg film-coated tablets are pink, oval and biconvex, with a score line on one side. The tablets can be divided into equal doses.
Rosuvastatina Pensa 40 mg film-coated tablets are pink, oblong and biconvex, with a score line on one side. The tablets can be divided into equal doses.
Rosuvastatina Pensa is supplied in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

Manufacturers
Biofarm Sp. z o.o
Ul.Walbrzyska 13
60-198 Poznan, Poland
SAG Manufacturing, S.L.U
Ctra. N-I, Km 36, San Agustín de Guadalix
28750 Madrid, Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7ª-1ª,
Edificio Lekla
Esplugues de Llobregat
08950, Barcelona, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Rosuvastatina Pensa